Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran eteksylan Polpharma, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dabigatran eteksylan Polpharma is and what it is used for
2. What you need to know before taking Dabigatran eteksylan Polpharma
3. How to take Dabigatran eteksylan Polpharma
4. Possible side effects
5. How to store Dabigatran eteksylan Polpharma
6. Contents of the pack and other information

1. What Dabigatran eteksylan Polpharma is and what it is used for

Dabigatran eteksylan Polpharma contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body responsible for blood clot formation.
Dabigatran eteksylan Polpharma is used in adults for:

• prevention of blood clots in veins following hip or knee replacement surgery.

Dabigatran eteksylan Polpharma is used in children for:

• treatment of blood clots and prevention of recurrence of blood clots.

2. Important information before taking Dabigatran eteksylan Polpharma

When not to take Dabigatran eteksylan Polpharma

• If the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe impairment of kidney function.
• If the patient is currently experiencing bleeding.
• If the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial hemorrhage, recent brain or eye surgery).
• If the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by the use of other medicines.
• If the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter where heparin is administered through the catheter to maintain its patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
• If the patient has severe impairment of liver function or liver disease which

may lead to death.

• If the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• If the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• If the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• If the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• If the patient has an artificial heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran eteksylan Polpharma, discuss this with your doctor.
If symptoms occur during treatment with Dabigatran eteksylan Polpharma or if the patient
needs to undergo a surgical procedure, consult a doctor.
The patient should inform the doctor if they have or have previously had
any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding;
• if the patient underwent a surgical tissue biopsy (biopsy) within the last month;
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment);
• if the patient has inflammation of the esophagus or stomach;
• if the patient has gastroesophageal reflux (regurgitation of stomach acid into the esophagus);
• if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran eteksylan Polpharma and other medicines”;
• if the patient is taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam;
• if the patient has an infection within the heart (bacterial endocarditis);
• if the patient has reduced kidney function or the patient is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) and/or foamy urine);
• if the patient is over 75 years of age;
• if the patient is an adult weighing 50 kg or less;
• only when used in children: if the child has an infection around or within the brain.
• after a previous heart attack or if the patient has been diagnosed with conditions increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such a case, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran eteksylan Polpharma

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran eteksylan Polpharma is necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran eteksylan Polpharma exactly as directed by the doctor before and after surgery.
• if the surgical procedure requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran eteksylan Polpharma exactly as directed by the doctor before and after surgery.
• the patient should immediately inform the doctor if numbness or weakness in the lower limbs, or problems with the intestines or bladder occur after the anesthesia wears off, as urgent medical care is required.
• if the patient falls or injures themselves during treatment, especially if the head is injured.

Immediate medical attention should be sought. The doctor will assess whether there is an increased risk of bleeding.

• if the patient has a disorder known as antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran eteksylan Polpharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has taken recently, as well as any medicines the patient plans to take. In particular, the patient should tell the doctor before taking Dabigatran eteksylan Polpharma if they are taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are used only on the skin;
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil); in patients taking medicines containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Dabigatran eteksylan Polpharma depending on the condition for which the medicine was prescribed. See also section 3.
• medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine);
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection);
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac);
• St. John's wort, an herbal medicine used to treat depression;
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors;
• rifampicin or clarithromycin (both antibiotics);
• antiviral medicines used to treat AIDS (e.g. ritonavir);
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran eteksylan Polpharma has on pregnancy or on the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran eteksylan Polpharma.
Breastfeeding should not be performed while taking Dabigatran eteksylan Polpharma.

Driving and operating machinery
The effect of Dabigatran eteksylan Polpharma on the ability to drive or operate machinery is unknown.

3. How to take Dabigatran eteksylan Polpharma

Dabigatran eteksylan Polpharma capsules can be used in adults, adolescents, and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are available for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor.
Dabigatran eteksylan Polpharma should be taken according to the following instructions:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran eteksylan Polpharma is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing verapamil who also have reduced renal function

over half, they should take a reduced dose of 75 mg of Dabigatran etexilate Polpharma due to an increased risk of bleeding.
In both types of procedures, treatment should not be initiated if there is bleeding from the surgical site. If treatment cannot be started by the next day after surgery, it should be initiated with a dose of 2 capsules once daily.

After knee joint replacement surgery
Treatment with Dabigatran etexilate Polpharma should be initiated by taking one capsule within 1 to 4 hours after completion of the surgical procedure. Then, two capsules once daily should be taken for a total of 10 days.

After hip joint replacement surgery
Treatment with Dabigatran etexilate Polpharma should be initiated by taking one capsule within 1 to 4 hours after completion of the surgical procedure. Then, two capsules once daily should be taken for a total of 28 to 35 days.

Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate Polpharma should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should ideally be 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran etexilate Polpharma in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Polpharma
Body weight and age ranges
Body weight in kg Age in years Single dose Total daily dose
in mg in mg
from 11 to less than 13 kg from 8 to less than 9 years 75 150
from 13 to less than 16 kg from 8 to less than 11 years 110 220
from 16 to less than 21 kg from 8 to less than 14 years 110 220
from 21 to less than 26 kg from 8 to less than 16 years 150 300
from 26 to less than 31 kg from 8 to less than 18 years 150 300
from 31 to less than 41 kg from 8 to less than 18 years 185 370
from 41 to less than 51 kg from 8 to less than 18 years 220 440
from 51 to less than 61 kg from 8 to less than 18 years 260 520
from 61 to less than 71 kg from 8 to less than 18 years 300 600
from 71 to less than 81 kg from 8 to less than 18 years 300 600
81 kg or more from 10 to less than 18 years 300 600

Single doses requiring combination of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule and one 150 mg capsule, or one 110 mg capsule and two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule and one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma can be taken with or without food. Capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening blister packs
The following pictogram illustrates how to remove Dabigatran etexilate Polpharma capsules from the blister pack.

Tear off an individual blister from the strip along the perforated line.

Remove the protective foil and take out the capsule.

• Do not push capsules through the blister foil.
• Do not remove the blister foil until the capsule is needed.

Switching anticoagulant medication
Do not switch anticoagulant medication without receiving specific instructions from your doctor.

Taking more than the recommended dose of Dabigatran etexilate Polpharma
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.

Missing a dose of Dabigatran etexilate Polpharma
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Dabigatran etexilate Polpharma at the usual time on the next day.
Do not take a double dose to make up for a missed dose.

Treatment of blood clots and prevention of recurrent blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma should be taken as directed by your doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.
Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran etexilate Polpharma.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dabigatran etexilate Polpharma affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding.
Severe or profuse bleeding may occur, which is the most serious adverse effect. Regardless of location, it may lead to disability, be life-threatening, or even result in death.
In some cases, such bleeding may not be visible.
If you experience bleeding that does not stop on its own, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to place you under close observation or change your treatment.
In case of a severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence.

Prevention of blood clots after surgery (hip or knee replacement)
Common (may affect up to 1 in 10 people):

• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• Bleeding from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into a joint, following injury or after a surgical procedure
• Formation of bruises or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid oozing from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

Rare (may affect up to 1 in 1,000 people):

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from wound
• Discharge of fluid from surgical wound

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in, or even absence of, white blood cells (which help fight infections)
• Hair loss

Treatment and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people):

• Decrease in white blood cells (which help fight infections)
• Bleeding into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or bleeding under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of eyes caused by liver or blood disease

Frequency not known (frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into a joint, from a wound, surgical incision site, injection site, or site of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dabigatran eteksylan Polpharma contains

• The active substance is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (in the form of mesilate), equivalent to 75 mg of dabigatran etexilate.
• Other components: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc, hydroxypropylcellulose (100 cps); the capsule shell contains: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps).

What Dabigatran eteksylan Polpharma looks like and contents of the pack
Dabigatran eteksylan Polpharma 75 mg is white or almost white, hard capsules of size 2, containing pellets ranging from almost white to pale yellow.
This medicinal product is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsule in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain

SAG Manufacturing, S.L.U.
Carretera Nacional 1 Km 36
28750 San Agustin de Guadalix, Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:
France: Dabigatran etexilate Galenicum Axium 75 mg, gélule
Spain: Dabigatrán etexilato Normon 75 mg, cápsulas duras EFG
Malta: Dabigatran etexilate Galenicum Axium 75 mg, hard capsule
Germany: Dabigatranetexilat Galenicum Axium 75 mg, Hartkapseln